FDA.reportPublic FDA data

cefuroxime axetil

Product NDC
57297-302
11-digit product format
572970302
Labeler code
57297
Product ID
57297-302_33afa15e-6c42-49e0-afc1-c3c5fb59e7ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefuroxime axetil
Dosage form
TABLET
Route
ORAL
Labeler
LUPIN LIMITED
Application
ANDA065135
Marketing category
ANDA
Marketing start
2003-07-25
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57297-302DDiscontinued by firm2026-07-31
excluded packagepackage57297-30257297-302-20DDiscontinued by firm2026-07-31
excluded packagepackage57297-30257297-302-60DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065135-001CEFUROXIME AXETILCEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25
A065135-002CEFUROXIME AXETILCEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25a50c72e98297…
2026-08-01 22:54:322026-06A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57297-302-202024-12-03C16284748780-19d75b9d0-f1fc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS USP safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS USP. CEFUROXIME axetil tablets USP, for oral use Initial U.S. Approval: 1987
57297-302-602024-12-03C16284748780-19d75b9d0-f1fc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS USP safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS USP. CEFUROXIME axetil tablets USP, for oral use Initial U.S. Approval: 1987
57297-302-202020-01-31C16284748780-19d75b9d0-f1fc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS USP safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS USP. CEFUROXIME axetil tablets USP, for oral use Initial U.S. Approval: 1987
57297-302-602020-01-31C16284748780-19d75b9d0-f1fc-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS USP safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS USP. CEFUROXIME axetil tablets USP, for oral use Initial U.S. Approval: 1987